SyneCare 1000 Deep Vein Thrombosis Prevention Therapy System

K203310 · Jiangsu Synecoun Medical Technology Co., Ltd. · JOW · Apr 2, 2021 · Cardiovascular

Device Facts

• Record ID: K203310
• Device Name: SyneCare 1000 Deep Vein Thrombosis Prevention Therapy System
• Applicant: Jiangsu Synecoun Medical Technology Co., Ltd.
• Product Code: JOW · Cardiovascular
• Decision Date: Apr 2, 2021
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.5800
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Synecare 1000 deep vein thrombosis prevention system is intended to be an easy to use portable system, prescribed by a physician, to help prevent the onset of DVT in patients by stimulating blood flow in the extremities (simulating muscle contractions). This device can be used in the home or clinical settings to: Aid in the prevention of DVT Enhance blood circulation Diminish post-operative pain and swelling Reduce wound healing time Aid in the treatment of: stasis dermatitis, venous stasis ulcers, arterial and diabetic leg ulcers, chronic venous insufficiency and reduction of edema in the lower limbs As a prophylaxis for DVT by persons expecting to be stationary for long periods of time

Device Story

Portable pneumatic compression system; prevents DVT by stimulating blood flow in lower limbs via cyclic inflation/deflation of sleeve bladders. Device consists of pump and sleeve assembly; operates at 50mmHg pressure with 60-second cycle time. Used in home or clinical settings; prescribed by physician; operated by patient or clinician. Microprocessor-controlled; one-button operation; includes audible/visual alarms for system faults. Benefits include improved circulation, reduced edema, and wound healing. Output is mechanical compression; healthcare provider uses device to provide prophylaxis for stationary patients or treatment for venous/diabetic conditions.

Clinical Evidence

No clinical or animal studies were conducted. Evidence is based on bench testing, including pressure accuracy, cycle time, alarm function, battery life, and air tightness. Biocompatibility (cytotoxicity, sensitization, irritation), electrical safety (IEC 60601-1), and EMC (IEC 60601-1-2) testing were performed. Software verification and validation were completed.

Technological Characteristics

Portable pneumatic compression device; PVC bladder with brushed Nylon cover. Microprocessor-controlled micropump; 50mmHg pressure; 60s cycle time. Powered by 3.7V Li-ion battery or AC. Single-patient use; non-sterile. Standards: IEC 60601-1 (safety), IEC 60601-1-2 (EMC), IEC 60601-1-6/62366 (usability), IEC 60601-1-11 (home healthcare).

Indications for Use

Indicated for patients requiring DVT prophylaxis via stimulation of blood flow in extremities (simulating muscle contractions). Also indicated for enhancing circulation, reducing post-op pain/swelling, accelerating wound healing, and treating stasis dermatitis, venous/arterial/diabetic ulcers, chronic venous insufficiency, and lower limb edema. Contraindicated in patients with severe arteriosclerosis, ischemic vascular disease, acute DVT, pulmonary edema, pulmonary embolism, congestive heart failure, neuropathy, active infections, thrombophlebitis, or conditions where increased venous/lymphatic return is undesirable (e.g., vein ligation, gangrene, open wounds, recent skin grafts, massive edema, or extreme deformity).

Regulatory Classification

Identification

A compressible limb sleeve is a device that is used to prevent pooling of blood in a limb by inflating periodically a sleeve around the limb.

Predicate Devices

• VenaPro (K133274)

Submission Summary (Full Text)

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April 2, 2021

Image /page/0/Picture/1 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: a symbol on the left and the FDA acronym with the full name of the agency on the right. The symbol on the left is a stylized representation of a human figure. To the right of the symbol is the FDA acronym in a blue box, followed by the words "U.S. FOOD & DRUG" in blue, with the word "ADMINISTRATION" underneath.

Jiangsu Synecoun Medical Technology Co., Ltd. Yue Li Project Manager East of 1/F. No. 50, G60, Eastside of Lujia Road, Westside of Koutai Road. CMC Taizhou, Jiangsu 225316 China

Re: K203310

Trade/Device Name: SyneCare 1000 Deep Vein Thrombosis Prevention Therapy System Regulation Number: 21 CFR 870.5800 Regulation Name: Compressible Limb Sleeve Regulatory Class: Class II Product Code: JOW Dated: February 11, 2021 Received: March 3, 2021

Dear Yue Li:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part

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801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4. Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely,

for Fernando Aguel Assistant Director DHT2B: Division of Circulatory Support, Structural and Vascular Devices OHT2: Office of Cardiovascular Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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# Indications for Use

Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2020 See PRA Statement below.

510(k) Number (if known)

K203310

#### Device Name

Synecare 1000 Deep Vein Thrombosis Prevention Therapy System

Indications for Use (Describe)

The Synecare 1000 deep vein thrombosis prevention system is intended to be an easy to use portable system, prescribed by a physician, to help prevent the onset of DVT in patients by stimulating blood flow in the extremities (simulating muscle contractions).

This device can be used in the home or clinical settings to:

· Aid in the prevention of DVT

- · Enhance blood circulation
· Diminish post-operative pain and swelling

- · Reduce wound healing time
· Aid in the treatment of: stasis dermatitis, venous stasis ulcers, arterial and diabetic leg ulcers, chronic venous insufficiency and reduction of edema in the lower limbs

· As a prophylaxis for DVT by persons expecting to be stationary for long periods of time

Type of Use (Select one or both, as applicable)

> Prescription Use (Part 21 CFR 801 Subpart D)

Over-The-Counter Use (21 CFR 801 Subpart C)

#### CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

#### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.*

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

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FORM FDA 3881 (7/17)

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# 510K Summary

# Submitter:

Jiangsu Synecoun Medical Technology Co.,Ltd. 1/2F East side No 50 Building G60 East of Lujia Road West of Koutai Road, CMC Taizhou Jiangsu, China Phone: [phone] Contact Person: Lei Zhu Date Prepare: October 9, 2020

## Device:

Common Names: Intermittent Pneumatic Compression Device Proprietary Name: SyneCare 1000 Deep Vein Thrombosis Prevention Therapy System Regulatory Class: II Product Code: JOW

## Predicate Devices:

The SyneCare 1000 Deep Vein Thrombosis Prevention Therapy System is equivalent to the following:

| Predicate Device | Manufacturer | 510(k)# |
|------------------|-----------------------|---------|
| VenaPro | Innovamed Health, LLC | K133274 |

#### Device Description

Premarket notification device:

SyneCare 1000 Deep Vein Thrombosis Prevention Therapy System

The SyneCare 1000 deep vein thrombosis prevention therapy system (referred as SyneCare 1000 below) is an easy to use portable pneumatic compression system that noninvasively helps prevent the onset of DVT in patients by stimulating blood flow in the extremities (simulating muscle contractions). The SyneCare 1000 system consists of a pair of pumps and sleeve assemblies.

The device will alternatively inflate and deflate the garment (sleeve) to stimulate blood flow in the extremities (muscle contraction). The device provides a 50mmHg pressure and followed by a deflation period once it reaches the desired pressure, each cycle time is 60 seconds

#### Intended Use:

The SyneCare 1000 deep vein thrombosis prevention system is intended to be an easy to use portable system, prescribed by a physician, to help prevent the onset of DVT in

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patients by stimulating blood flow in the extremities (simulating muscle contractions). This device can be used in the home or clinical settings to:

- Aid in the prevention of DVT •
- Enhance blood circulation
- Diminish post-operative pain and swelling
- . Reduce wound healing time
- Aid in the treatment of: stasis dermatitis, venous stasis ulcers, arterial and diabetic leg ulcers, chronic venous insufficiency and reduction of edema in the lower limbs
- As a prophylaxis for DVT by persons expecting to be stationary for long periods of time.

#### Technological Characteristics:

Below is a table of comparison for the technological characteristics against the predicate device:

| Feature | SyneCare 1000 | VenaPro | S/D |
|------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----|
| Manufacturer | Jiangsu Synecoun Medical<br>Technology Co.,Ltd. | Innovamed Health, LLC | S |
| FDA 510(k) | This submission | K133274 | S |
| Indications for Use | The SyneCare 1000 deep vein<br>thrombosis prevention system is<br>intended to be an easy to use<br>portable system, prescribed by a<br>physician, to help prevent the<br>onset of DVT in patients by<br>stimulating blood flow in the<br>extremities (simulating muscle<br>contractions).<br><br>This device can be used in the<br>home or clinical setting to:<br>* Aid in the prevention of DVT<br>* Enhance blood circulation<br>* Diminish post-operative pain<br>and swelling<br>* Reduce wound healing time<br>"Aid in the treatment of stasis<br>dermatitis, venous stasis ulcers,<br>arterial and diabetic leg<br>ulcers, chronic venous<br>insufficiency and reduction of<br>edema in the lower limbs;<br>* As a prophylaxis for DVT by<br>persons expecting to be<br>stationary for long periods of<br>time | The VenaPro Vascular Therapy<br>System model VP-31 ill is<br>intended to be an easy to use<br>portable system, prescribed by a<br>physician, to help prevent the<br>onset of DVT in patients by<br>stimulating blood flow in the<br>extremities (simulating muscle<br>contractions).<br><br>This device can be used in the<br>home or clinical settings to:<br>•Aid in the prevention of DVT<br>•Enhance blood circulation<br>•Diminish post-operative pain<br>and swelling<br>•Reduce wound healing time<br>•Aid in the treatment of stasis<br>dermatitis, venous stasis ulcers,<br>arterial and diabetic leg ulcers,<br>chronic venous insufficiency and<br>reduction of edema in the lower<br>limbs<br>•As a prophylaxis for DVT by<br>persons expecting to be<br>stationary for long periods of<br>time | S |
| Prescription Use | Yes | Yes | S |
| Contraindications | The SyneCare 1000 series<br>system should NOT be used<br>in the following conditions:<br>Severe<br>arteriosclerosis or<br>other ischemic<br>vascular diseases Acute or active deep vein<br>thrombosis Existing pulmonary<br>edema, pulmonary<br>embolisms, and/or<br>congestive cardiac<br>failure On patients with<br>neuropathy, active<br>infections, and/or<br>thrombophlebitis On extremities that are<br>extremely deformed,<br>insensitive to pain, or<br>where increased venous<br>or lymphatic return is<br>undesirable Any local skin or<br>tissue condition in<br>which the garments<br>would interfere<br>including but not<br>limited to: Vein ligation Gangrene Open wounds Recent skin graft Dermatitis Massive edema | The VenaPro Vascular Therapy<br>System model VP-3 1111 <b>must<br/>not</b> be used to treat the following<br>conditions:<br>Persons with suspected, active<br>or untreated: deep vein<br>thrombosis, ischemnic vascular<br>disease, severe arteriosclerosis,<br>pulmonary edema, congestive<br>heart failure, thrombophlebitis or<br>an active infection On a leg where cuffs would<br>interfere with the following<br>conditions: vein ligation,<br>gangrene, dermatitis, open<br>wounds, a recent skin graft,<br>massive edema or extreme<br>deformity of the leg On patients with neuropathy On extremities that are<br>insensitive to pain Where increased venous or<br>lymphatic return is undesirable | S |
| Use settings | Home and clinical | Home and clinical | S |
| Application | Non-invasive / external | Non-invasive / external | S |
| Portability | Portable, ambulant | Portable, ambulant | S |
| Basis of<br>operation | Aids venous return by using<br>cyclic, intermittent, pneumatic<br>pressure<br>application (inflation followed<br>by deflation) to compress the<br>lower Hmb(s). | Aids venous return by using<br>cyclic, intermittent, pneumatic<br>pressure<br>application (inflation followed<br>by deflation) to compress the<br>lower Hmb(s). | S |
| Location of<br>treatment<br>application | Lower limb(s) (Calf) | Lower limb(s) (Calf) | S |
| System<br>management | Electronic,<br>microprocessor controlled | Electronic,<br>microprocessor controlled | S |
| Treatment<br>delivery | Uses electronic<br>microprocessor and<br>pneumatics to inflate and<br>deflate bladder cuffs to<br>achieve compression | Uses electronic<br>microprocessor and<br>pneumatics to inflate and<br>deflate bladder cuffs to<br>achieve compression | S |
| Pressure Source | Micropump controlled by<br>electronic processor | Micropump controlled by<br>electronic processor | S |
| Physical components | Pump and sleeve come<br>assembled | Pump and sleeve come<br>assembled | S |
| Operating<br>Modes | One | One | S |
| Cycle time<br>(One inflation<br>and deflation<br>per limb) | Preset at 60 seconds | Preset at 60 seconds | S |
| Pressure | 50mmHg | 50mmHg | S |
| GUI | No | No | S |
| User interface | One-button operation | One-button operation | S |
| System<br>diagnostics | Audible and visual alarms<br>prompt recognition of<br>system faults | Audible and visual alarms<br>prompt recognition of<br>system faults | S |
| Leg cuffs<br>(garments)<br>material | PVC bladder covered with<br>brushed Nylon | PVC bladder covered with<br>brushed Nylon | S |
| Leg cuff Sterile<br>/Not Sterile | Clean / non sterile | Clean / non sterile | S |
| Leg cuff usage | Single patient use | Single patient use | S |
| Battery | 3.7 V Li-ion Battery | 7.4 V Li-ion Battery | D |
| Power<br>Requirement | Rechargeable battery<br>and/or AC | Rechargeable battery<br>and/or AC | S |
| | *D – Different | *S - Same | |

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The SyneCare 1000 and VenaPro are very similar in construction and operation principle. Both devices work in a preset 50mmHg with one button to control the start/stop of the therapy.

SyneCare1000 and VenaPro use different batteries. Though SyneCare 1000 has a lower voltage battery, battery tests and functional tests were conducted to ensure the difference in battery does not affect the effectiveness of the device.

In summary, the SyneCare 1000 is substantially equivalent in device construction, indications for use and contraindications for use to the predicate VenaPro (K133274). Any noted differences between the devices do no raise new issues of the safety and effectiveness. All the results demonstrate that the SyneCare 1000 DVT performs equivalently to the predicate devices .

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# Performance Tests

To verify that the device design met its function and performance requirements, samples of the device underwent function and mechanical testing. The following tests were conducted:

| Function Performance Tests | |
|----------------------------|-------------------------------|
| RDTR-IP-001.01 | Pressure Accuracy Test Report |
| RDTR-IP-002.01 | Cycle Time Test Report |
| RDTR-IP-003.01 | Alarm Function Test Report |
| RDTR-IP-004.01 | Battery Life Test Report |
| RDTR-IP-005.01 | Air Tightness Test Report |

The conclusions drawn from the performance tests demonstrate that the device is performing as intended and is substantially equivalent to the predicate.

#### Biocompatibility

For the sleeve, the SyneCare 1000 uses the same direct body contact method.Biocompatibility testing was done at CCIC Huatongwei International Inspection (Suzhou) Co.,Ltd. The following tests were done:

- . Cytotoxicity
- Sensitization
- Irritation

#### Sterilization and Shelf Life

Sterilization is not applicable to SyneCare 1000.

The shelf life of the product is 3 years. The shelf life was verified.

The following tests were done:

- SyneCare 1000 Accelerated Aging Test Report
#### Electrical Safety and Electromagnetic Compatibility (EMC)

EMC tests were conducted according to the following standards:

- . IEC 60601-1: 2005 Medical electrical equipment Part 1: General requirements for basic safety and essential performance
- IEC 60601-1-2: 2014 Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral Standard: Electromagnetic disturbances - Requirements and tests
- IEC 60601-1-6:2010 Medical electrical equipment Part 1-6: General requirements for . safety - Collateral Standard: Usability including IEC 62366: Application of usability engineering to medical devices

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- IEC 60601-1-11: 2015 Medical electrical equipment Part 1-11: General requirements for basic safety and essential performance - Collateral Standard: Requirements for medical electrical equipment and medical electrical systems used in the home healthcare environment
#### Software Verification and Validation

Software verification and validation was conducted and documentation is provided. The software was considered as a "moderate" level of concern", since a failure or latent flaw in the software could directly result in serious injury to the patient or operator.

## Animal Study and Clinical Study

No animal study or clinical study was conducted.

## Statement of Substantial Equivalence

The SyneCare 1000 Deep Vein Thrombosis Prevention Therapy System is substantially equivalent in technology, function, operating parameters, and intended use to predicate devices that are currently commercially available and in distribution, and does not raise any new questions of safety or effectiveness.